TCT: PFO Closure Back in Spotlight

MIAMI -- After disappointing results with closure of patent foramen ovale for cryptogenic stroke prevention in recent years, the procedure will be making headlines again at the Transcatheter Therapeutics meeting here.

Two PFO closure trials slated for presentation at the meeting next Thursday -- RESPECT done in the U.S. and the PC Trial from Europe -- promise to be blockbusters.

"Depending on whether these trials are positive or negative could have a very deep impact on the way we treat patients with cryptogenic stroke," Gregg W. Stone, MD, of Columbia University in New York City, said at a press briefing ahead of the conference he co-directs.

Possibly tens of thousands of PFO closures have already been done based on the theory that closing these right to left shunts through the heart would stop clots and thus recurrent strokes in patients without any clear explanation for their initial event.

The only prior randomized trial to test that theory, CLOSURE I, turned up negative results.

As reported at the American Heart Association meeting in late 2010 and released in the New England Journal of Medicine in early 2012, the STARFlex PFO closure device had no impact on the composite risk of stroke, transient ischemic attack, or death from neurologic causes.

"But [that trial] used a less than optimal device, and it also is criticized for not enrolling the right kind of patients," Stone explained.

Positive findings from the two new trials, both using the Amplatzer device, will either strike the death blow or lead to an explosion in PFO closure, he predicted.

"That would create a whole new subspecialty basically or it could arguably end that subspecialty," he told MedPage Today at the briefing.

Other potentially practice changing late-breaking clinical trials that will be presented at the meeting include the XIMA trial comparing everolimus-eluting stents to bare metal stents in elderly patients in their 80s and the first report from Stone's MASTER trial testing a new kind of mesh-coated stent to trap thrombi.

"When we use a standard stent, we very frequently break off the blood clots and they embolize downstream and they clog up all the distal little vessels and that can make the heart attack larger and lead to death," Stone explained.

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